ClinicalTrials.gov
ClinicalTrials.gov Menu

BioFeedBack Breathing Training Influence Cardiac Autonomic Nervous System in Children With Cerebral-Palsy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01872507
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
BERGER ITAI, Hadassah Medical Organization

Brief Summary:

The effect of breathing biofeedback training to influence the function of the cardiac autonomic nervous system at rest and in activity in children with cerebral palsy.

Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most common injury that causes physical handicapped in childhood. There are a few researches that investigated the autonomic function in cerebral palsy children. Those researches found hyperactivity of the sympathetic autonomic system, including high resting heart rate compare to their typically developed pears. The recommended treatment for cerebral palsy is activity, muscle strengthening and mobility. The impairment in the autonomic system influences the everyday function and has correlation with secondary morbidity.

As far as we know there are no researches who investigated the following issues.

In this study we would like to:

  1. Describe the autonomic cardiac function, Breathing function, motor function and the correlation between them in children with cerebral palsy.
  2. Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic breathing.
  3. Test the influence of breathing training on Heart rate variability parameters at rest, in aerobic test right after the breathing training program and one month after, in children with cerebral palsy

Condition or disease Intervention/treatment Phase
Cerebral Palsy Autonomic Nerveus System Other: Biofeedback training Not Applicable

Detailed Description:

Participants:

60 children with cerebral palsy age 6-11 who can walk and understand simple instructions.

Main outcome measures:

Heart rate variability using Polar watch and transmitter RS810CX.

Secondary outcome measures:

  1. Lung functioning using Sensormedics Vmax 29 spirometry:Forced Vital Capacity, Forced Expiratory Volume in one,Tidal Volume.
  2. Biofeedback
  3. Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter.
  4. Gross Motor Function Classification System
  5. Gross Motor Function Measure
  6. Functional Mobility Scale
  7. Children Assessment of Participation and Enjoyment
  8. Autonomic function questionnaire

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Breathing Biofeedback Training to Influence the Function of the Cardiac Autonomic Nervous System at Rest and in Activity in Children With Cerebral Palsy.
Actual Study Start Date : July 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: biofeedback training
usual treatment+12 treatment of biofeedback training
Other: Biofeedback training
usual treatment +12 biofeedback training
No Intervention: control
usual treatment



Primary Outcome Measures :
  1. Change from Baseline of Heart rate variability meaures at one and two months [ Time Frame: Change from Baseline at one and two months ]

Secondary Outcome Measures :
  1. Change from Baseline of Forced Vital Capacity, Forced Expiratory Volume in one, Tidal Volume, [ Time Frame: Change from Baseline at one and two month ]
  2. Change from Baseline Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter. [ Time Frame: Change from baseline at one and two month later ]
  3. Change from baseline breathing rate, by biofeedback [ Time Frame: Change from baseline at one and two month later ]

Other Outcome Measures:
  1. Change from baseline Gross Motor Function Measure [ Time Frame: Change from baseline at one and two month later ]
  2. Change from baseline Children Assessment of Participation and Enjoyment [ Time Frame: Change from baseline at one and two month later ]
  3. Change from baseline Autonomic function questionnaire [ Time Frame: Change from baseline at one and two month later ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with cerebral palsy
  • age 6-11 years
  • able to walk
  • both gender

Exclusion Criteria:

  • heart or lung known disease
  • can not follow simple commends

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872507


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91240
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Itai Berger, MD Hadassah Medical Organization

Publications:
Responsible Party: BERGER ITAI, Director Neuro-Cognitive Center Pediatric Wing, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01872507     History of Changes
Other Study ID Numbers: HMO-0374-12
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by BERGER ITAI, Hadassah Medical Organization:
cerebral palsy
autonomic nerveus system
heart rate variability

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases